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Walking and Balance Post-TBI

Primary Purpose

Difficulties, Ambulation, Brain Injuries, Traumatic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensive Mobility Training (IMT)

About this trial

This is an interventional treatment trial for Difficulties, Ambulation focused on measuring physical therapy techniques, brain injuries, traumatic, walking, gait, postural balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
the ability to follow simple three-step commands;
the ability to communicate presence and location of pain;
the ability to sit independently without back or arm support for five minutes;
the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
the ability to walk 10 meters with maximum 1 person assisting;
presence of motor deficits (determined by clinical assessment of paresis);
age ≥ 18;
ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf

Exclusion Criteria:

unable to ambulate 500 feet prior to TBI;
history of serious chronic obstructive pulmonary disease or oxygen dependence;
severe weight bearing pain;
lower-extremity amputation;
non-healing ulcers on the lower-extremity;
renal dialysis or end stage liver disease;
legal blindness or severe visual impairment;
severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
history of deep venous thrombosis or pulmonary embolism within 6 months
uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
history of severe uncontrolled seizure disorder;
other neurological conditions such as multiple sclerosis or Parkinson's Disease;
pain that is scored greater than 5 out of 10 on a visual analog scale;
any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
any other health problems judged by their screening physician to put the client at significant risk of harm during the study

Sites / Locations

921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensive Mobility Training (IMT)

Arm Description

Intensive Mobility Training will be used as an intensive physical therapy intervention. Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.

Outcomes

Primary Outcome Measures

Feasibility as measured by study completion.

Feasibility will be determined by the ratio of participants that complete the intervention.

Feasibility as measured by pain ratings.

Feasibility will be determined by daily change in pain scores as measured using visual analog scales.

Feasibility as measured by fatigue ratings.

Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.

Secondary Outcome Measures

Efficacy as measured by improvements in gait and mobility.

Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.

Full Information

NCT ID

NCT01418976

First Posted

August 16, 2011

Last Updated

April 25, 2013

Sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Collaborators

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT01418976

Brief Title

Walking and Balance Post-TBI

Official Title

IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Collaborators

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a case series study evaluating the feasibility and dosage of Intensive Mobility Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury (TBI) causing significant locomotor impairment, who meet these specific criteria, will be recruited. Location and nature of neural insult will be determined by multimodal Magnetic Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This study will determine the feasibility of this intervention in the population of TBI patients, allow an estimate of effect size and provide initial information on possible neural predictors of success. Furthermore the investigators will be able to determine whether the dosage of 10 days is sufficient or whether significant improvements are made with 20 days of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Difficulties, Ambulation, Brain Injuries, Traumatic

Keywords

physical therapy techniques, brain injuries, traumatic, walking, gait, postural balance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive Mobility Training (IMT)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Intensive Mobility Training (IMT)

Intervention Description

Primary Outcome Measure Information:

Title

Feasibility as measured by study completion.

Description

Feasibility will be determined by the ratio of participants that complete the intervention.

Time Frame

post-treatment (after 20-day intervention)

Title

Feasibility as measured by pain ratings.

Description

Feasibility will be determined by daily change in pain scores as measured using visual analog scales.

Time Frame

during 20-day intervention

Title

Feasibility as measured by fatigue ratings.

Description

Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.

Time Frame

during 20-day intervention

Secondary Outcome Measure Information:

Title

Efficacy as measured by improvements in gait and mobility.

Description

Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.

Time Frame

from pre- to post-treatment during 20-day intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility. the ability to follow simple three-step commands; the ability to communicate presence and location of pain; the ability to sit independently without back or arm support for five minutes; the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes; the ability to walk 10 meters with maximum 1 person assisting; presence of motor deficits (determined by clinical assessment of paresis); age ≥ 18; ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf Exclusion Criteria: unable to ambulate 500 feet prior to TBI; history of serious chronic obstructive pulmonary disease or oxygen dependence; severe weight bearing pain; lower-extremity amputation; non-healing ulcers on the lower-extremity; renal dialysis or end stage liver disease; legal blindness or severe visual impairment; severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°); history of deep venous thrombosis or pulmonary embolism within 6 months uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions; severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest; intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded); history of severe uncontrolled seizure disorder; other neurological conditions such as multiple sclerosis or Parkinson's Disease; pain that is scored greater than 5 out of 10 on a visual analog scale; any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body). any other health problems judged by their screening physician to put the client at significant risk of harm during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stacy Fritz, Ph.D., P.T.

Organizational Affiliation

University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29208

Country

United States

12. IPD Sharing Statement

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Walking and Balance Post-TBI

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